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Music's Effects on Anxiety During Epidural Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03844659
Recruitment Status : Completed
First Posted : February 18, 2019
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
David Gutman, Medical University of South Carolina

Study Description
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Brief Summary:
The objective of the study is to determine if playing the song "Weightless" by Marconi Union during labor epidural placement, decreases laboring parturient anxiety and improves satisfaction with the experience.

Condition or disease Intervention/treatment Phase
Anxiety Satisfaction Other: Song "Weightless" by Marconi Union Other: No Song Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial of Playing "The Most Relaxing Song in the World" During Labor Epidural Placement and Its Effects on Anxiety and Satisfaction
Actual Study Start Date : October 19, 2018
Actual Primary Completion Date : December 24, 2020
Actual Study Completion Date : December 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Group
The song "Weightless" by Marconi Union will be playing during subjects labor epidural placement.
 Other: Song "Weightless" by Marconi Union
Patients will be randomized to the intervention group (the song "Weightless" by Marconi Union will be playing) during subjects labor epidural placement. The intervention in this study is solely the addition of music.
Non Intervention Group
No song will be played during subjects labor epidural placement.
 Other: No Song
No song will be played during subjects labor epidural placement.


Outcome Measures
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Primary Outcome Measures :
  1. Mean Score of Anxiety Before Epidural Placement [ Time Frame: Immediately prior to procedure ]
    3 different measures of anxiety prior to the procedure based on the State Trait Anxiety Inventory: 1) Numeric Rating Scale from 0-10 with 0 representing no anxiety and 10 representing worst anxiety possible. 2) Asking patient response to the question "Are you calm" with options scaling from "very much, moderately, somewhat, or not at all". 3) Asking the patient to answer the question "are you relaxed?" with options scaling from "very much, moderately, somewhat, or not at all." "Very much" will be treated as a positive finding and "moderately, somewhat, or not at all" as negative. The short form of the State Trait Anxiety Inventory with these three measures has been shown to be a reliable measure of anxiety. A fourth measure used will be a Visual Analog Scale from 0-100 of overall anxiety with 0 representing no anxiety and 100 representing the worst anxiety possible.

  2. Mean Score of Anxiety After Epidural Placement [ Time Frame: Immediately after procedure ]
    As soon as the epidural has been placed and appropriate documentation for the procedure is completed, both groups will take the same surveys again.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant females
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Females ages 18 years and older committed to delivery by the obstetrical team (natural labor or induction of labor)
  • English speaking
  • Able to give informed consent
  • Having an epidural placed Exclusion Criteria
  • Patient refusal
  • Intrauterine fetal demise
  • Imminent delivery
  • Existing music use
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844659


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
More Information
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Responsible Party: David Gutman, Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03844659    
Other Study ID Numbers: 00078958
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders